Duodenal DiseasesNCT06200129
İmportance of Scattered White Spots Detected in the Duodenum and Their Relationship wıth Zonulin
A study testing sws grade 1 and sws grade 2 in people with Duodenal Diseases and White Spot Lesion, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
With our study, we aimed to determine whether there is a correlation between zonulin, which plays a crucial role in intestinal barrier function and is implicated in the etiopathogenesis of many chronic and autoimmune diseases, and scattered white spots lesions associated with lymphatic stasis and inflammation in the… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Duodenal Diseases, White Spot Lesion
- What is being tested?
- sws grade 1 and sws grade 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with scattered white patchy lesions in the duodenum on endoscopy and control group patients with normal duodenum on endoscopy.
Who cannot join
- active gastroenteritis
- acute kidney failure
- chronic kidney failure
- type-1 diabetes
- inflammatory bowel disease
- duodenal ulcer,
- duodenal tumor
- autoimmune diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara
About this study
With our study, we aimed to determine whether there is a correlation between zonulin, which plays a crucial role in intestinal barrier function and is implicated in the etiopathogenesis of many chronic and autoimmune diseases, and scattered white spots lesions associated with lymphatic stasis and inflammation in the duodenum.
Read the detailed description
During esophagogastroduodenoscopy (EGD), rarely encountered lesions in the duodenum present as scattered white spots (SWS) on the normal mucosa. Although not fully understood in terms of specific association with any particular disease and clinical significance, some studies have often observed chronic non-specific duodenitis (CND) and intestinal lymphangiectasia (IL) in lesions with SWS. This condition is thought to be related to lymphatic stasis.
Patients included 63 individuals with identified SWS during EGD and 30 patients with a normal appearance of the duodenal mucosa were selected as the control group. SWS lesions were categorized into two groups, grade 1 and grade 2, based on the degree of density and endoscopic appearance. Biopsies were taken from the duodenum, antrum, and corpus. It was examined for IL, CND, giardiasis, and villous atrophy. Venous blood samples were collected from all patients for serum zonulin levels.
- Conditions
- Duodenal Diseases, White Spot Lesion
- Being tested
- sws grade 1, sws grade 2, control
- Medical subject headings
- Duodenal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sws grade 1Diagnostic test
Blood for zonulin level was drawn from the group of patients with typical white lesions in the duodenum, called grade 1.
sws grade 2Diagnostic test
Blood for zonulin level was drawn from the group of patients with typical white lesions in the duodenum, called grade 2
controlDiagnostic test
Group of patients without scattered white lesions in the dueodenum on endoscopy.
| Study group | Role | What they receive |
|---|---|---|
| sws grade 1 | Experimental | The group that defined as scattered white spots on the normal duodenal mucosa that could not be wiped away by washing, appearing as white spots Receives: Diagnostic Test: sws grade 1 |
| sws grade 2 | Experimental | The group that defined as a diffuse or patchy white appearance on villi that could not be wiped away by washing on the mucosa. Receives: Diagnostic Test: sws grade 2 |
| control | Experimental | The group with a normal appearance of the duodenal mucosa, where scattered white spots were not detected. Receives: Diagnostic Test: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
zonulin levels
Patients with scattered white spots in the duodenum had blood drawn for zonulin level immediately after the procedure.
Measured: immediately after the procedure
Secondary outcomes (1)
Duodenal and gastric pathologic conditions
Biopsies from the duodenum and gastric antrum and corpus were taken during the endoscopy from patients with scattered white spots in the duodenum.
Measured: During the endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Sep 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Duodenal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semih Sezer, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Investigators
- semih sezer, Principal investigator, clinic physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200129
- Sponsor's protocol ID
- zonulinsws
- Status last verified
- Dec 2023
- First submitted
- 29 Dec 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tas A, Koklu S, Beyazit Y, Akbal E, Kocak E, Celik H, Biyikoglu I. The endoscopic course of scattered white spots in the descending duodenum: a prospective study. Gastroenterol Hepatol. 2012 Feb;35(2):57-64. doi: 10.1016/j.gastrohep.2011.11.010. Epub 2012 Jan 20.
PubMed 22260755Fasano A, Shea-Donohue T. Mechanisms of disease: the role of intestinal barrier function in the pathogenesis of gastrointestinal autoimmune diseases. Nat Clin Pract Gastroenterol Hepatol. 2005 Sep;2(9):416-22. doi: 10.1038/ncpgasthep0259.
PubMed 16265432Biyikoglu I, Babali A, Cakal B, Koklu S, Filik L, Astarci MH, Ustun H, Ustundag Y, Akbal E. Do scattered white spots in the duodenum mark a specific gastrointestinal pathology? J Dig Dis. 2009 Nov;10(4):300-4. doi: 10.1111/j.1751-2980.2009.00399.x.
PubMed 19906109
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- İmportance of Scattered White Spots Detected in the Duodenum and Their Relationship wıth Zonulin
- ClinicalTrials.gov ID
- NCT06200129
- Acronym / sponsor ID
- zonulinsws
- Conditions
- Duodenal Diseases, White Spot Lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With our study, we aimed to determine whether there is a correlation between zonulin, which plays a crucial role in intestinal barrier function and is implicated in the etiopathogenesis of many chronic and autoimmune diseases, and scattered white spots lesions associated with lymphatic stasis and inflammation in the duodenum.
Detailed description
During esophagogastroduodenoscopy (EGD), rarely encountered lesions in the duodenum present as scattered white spots (SWS) on the normal mucosa. Although not fully understood in terms of specific association with any particular disease and clinical significance, some studies have often observed chronic non-specific duodenitis (CND) and intestinal lymphangiectasia (IL) in lesions with SWS. This condition is thought to be related to lymphatic stasis.
Patients included 63 individuals with identified SWS during EGD and 30 patients with a normal appearance of the duodenal mucosa were selected as the control group. SWS lesions were categorized into two groups, grade 1 and grade 2, based on the degree of density and endoscopic appearance. Biopsies were taken from the duodenum, antrum, and corpus. It was examined for IL, CND, giardiasis, and villous atrophy. Venous blood samples were collected from all patients for serum zonulin levels.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sws grade 1 | Experimental | Diagnostic Test: sws grade 1The group that defined as scattered white spots on the normal duodenal mucosa that could not be wiped away by washing, appearing as white spots |
| sws grade 2 | Experimental | Diagnostic Test: sws grade 2The group that defined as a diffuse or patchy white appearance on villi that could not be wiped away by washing on the mucosa. |
| control | Experimental | Diagnostic Test: controlThe group with a normal appearance of the duodenal mucosa, where scattered white spots were not detected. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with scattered white patchy lesions in the duodenum on endoscopy and control group patients with normal duodenum on endoscopy.
Key exclusion criteria (8 listed)
- active gastroenteritis
- acute kidney failure
- chronic kidney failure
- type-1 diabetes
- inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sws grade 1Blood for zonulin level was drawn from the group of patients with typical white lesions in the duodenum, called grade 1. | Diagnostic test | sws grade 1 |
| sws grade 2Blood for zonulin level was drawn from the group of patients with typical white lesions in the duodenum, called grade 2 | Diagnostic test | sws grade 2 |
| controlGroup of patients without scattered white lesions in the dueodenum on endoscopy. | Diagnostic test | control |
Primary outcome
zonulin levels
Time frame: immediately after the procedure
Patients with scattered white spots in the duodenum had blood drawn for zonulin level immediately after the procedure.
1 secondary outcome
Duodenal and gastric pathologic conditions
Time frame: During the endoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Results publication: PubMed 22260755Tas A, Koklu S, Beyazit Y, Akbal E, Kocak E, Celik H, Biyikoglu I. The endoscopic course of scattered white spots in the descending duodenum: a prospective study. Gastroenterol Hepatol. 2012 Feb;35(2):57-64. doi: 10.1016/j.gastrohep.2011.11.010. Epub 2012 Jan 20.
- Results publication: PubMed 16265432Fasano A, Shea-Donohue T. Mechanisms of disease: the role of intestinal barrier function in the pathogenesis of gastrointestinal autoimmune diseases. Nat Clin Pract Gastroenterol Hepatol. 2005 Sep;2(9):416-22. doi: 10.1038/ncpgasthep0259.
- Results publication: PubMed 19906109Biyikoglu I, Babali A, Cakal B, Koklu S, Filik L, Astarci MH, Ustun H, Ustundag Y, Akbal E. Do scattered white spots in the duodenum mark a specific gastrointestinal pathology? J Dig Dis. 2009 Nov;10(4):300-4. doi: 10.1111/j.1751-2980.2009.00399.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
semih sezer principal investigator
clinic physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sws grade 1 and sws grade 2 in people with Duodenal Diseases and White Spot Lesion, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
zonulin levels (time frame: immediately after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06200129, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.